Amgen is a global biotechnology leader committed to innovative therapies for serious illnesses. With a strong focus on patient safety and regulatory compliance, Amgen offers dynamic career opportunities in pharmacovigilance and drug safety.

Job Description: Sr. Associate Pharmacovigilance Operations

Key Responsibilities:

✔ Authoring & Compiling Periodic Aggregate Safety Reports (PASRs)

• DSUR, PBRER/PSUR, SSUR, PADER/PAER, Device PSUR, and country-specific reports (e.g., Korea PSUR, Brazil PSUR).
  ✔ Stakeholder Coordination
• Schedule cross-functional meetings, manage timelines, and escalate risks.
  ✔ Safety Content Writing
• Collaborate with Therapeutic Area Safety Scientists to draft safety sections.
  ✔ Quality Control & Compliance
• Conduct peer QC, manage approvals, and ensure adherence to regulatory guidelines.
  ✔ Report Distribution
• Handle distribution to CROs (Contract Research Organizations) and Business Partners (BPs).
  ✔ Metrics & Compliance Tracking
• Generate Key Compliance Indicators (KCIs) & Key Performance Indicators (KPIs).

Additional Responsibilities (if required):

• Assist with Literature Management processes.

Eligibility & Qualifications

✅ Education: Bachelor’s or Master’s in Life Sciences/Pharmacy.
✅ Experience:

• Total: 5–9 years
• Periodic Report Writing: 2–3 years (mandatory)
  ✅ Skills Required:
• Strong regulatory knowledge (ICH, GVP, FDA/EMA guidelines).
• Expertise in pharmacovigilance operations & safety reporting.
• Excellent scientific writing & peer review abilities.

Benefits of Working at Amgen

✨ Competitive Salary & Bonus
✨ Health & Wellness Programs
✨ Career Growth in Global Biotech
✨ Work-Life Balance (Hybrid Options)
✨ Learning & Development Opportunities

How to Apply

Application Link